Projektleiter:in Regulatory Affairs – Medizinsoftware
Core
Leading certification projects for medical software under the Medical Device Regulation (MDR), coordinating cross-functional teams, and ensuring regulatory compliance.
Role type
Senior Project Manager, Regulatory Affairs (Medical Software)
Builds
Certified medical software products
Domain
Medical Technology / Regulatory Compliance
Required skills
Project management, MDR expertise, cross-functional coordination, documentation management, budget and resource planning, stakeholder communication
Preferred skills
Experience in regulated industries (MedTech, Pharma, Automotive, Aviation, Finance), knowledge of ISO 9001/13485/27001, audit experience, AI tool proficiency
Technologies
MDR, ISO 9001, ISO 13485, ISO 27001, AI tools
Responsibilities
Steer certification projects from planning to completion, coordinate between development, product management, and quality teams, manage documentation and evidence, report to executive leadership, optimize release and change processes
Seniority
Senior, hands-on IC